medwireNews: The DEPICT-2 findings confirm those of DEPICT-1, with dapagliflozin producing improved glycemic control and weight loss, and reduced insulin need, in patients with type 1 diabetes.
However, in line with the 52-week results of DEPICT-1 and the inTandem1 trial, use of the sodium-glucose cotransporter (SGLT)2 inhibitor was associated with a slight but significant increase in diabetic ketoacidosis (DKA).
During 24 weeks of treatment with dapagliflozin, 2.6% of the 271 patients taking the 5 mg dose had DKA events, as did 2.2% of the 270 patients taking the 10 mg dose and none of the 272 taking placebo.
Nonetheless, patients also achieved significant 0.37% and 0.42% reductions in average glycated hemoglobin levels with the 5 and 10 mg doses, respectively, relative to placebo, and a corresponding 39.5% and 41.6% versus 20.1% achieved the secondary composite endpoint of an HbA1c reduction of at least 0.5% without severe hypoglycemia.
Patients taking dapagliflozin also had significant weight reductions versus placebo, of 3.40% and 3.74% with the 5 and 10 mg doses, respectively, and reduced their insulin requirements, by a corresponding 10.78% and 11.08%.
The study participants underwent continuous glucose monitoring at baseline and 24 weeks, revealing a 9–10% improvement versus the placebo group in the proportion of time patients spent within the blood glucose range of 70–180 mg/dL.
Chantal Mathieu (KU Leuven, Belgium), who presented the results to the press at the ADA’s 78th Scientific Sessions in Orlando, Florida, USA, said that time in range is a “very important parameter in my eyes as a clinician,” and stressed that the improvement seen with dapagliflozin “is in the same ballpark as what you can achieve with the almost closed-loop systems that we have at the moment.”
Discussing the DKA findings while presenting the results to conference attendees, co-researcher Paresh Dandona (State University of New York at Buffalo, USA) suggested that “we have to live with the fact” that SGLT2 inhibitors increase DKA risk in type 1 diabetes patients, stressing that this is an area “where we’ve been bereft of treatments” except those relating to new insulin formulations and delivery systems.
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